Kornimate/medical-research-clean huggingface dataset:
study of mood effects of varenicline (chantix) in depressed outpatient smokers

Conditions: Depressive Disorder; Smoking

Summary: this study will assess whether varenicline (chantix) has antidepressant properties when used in addition to other psychiatric medication. it will also assess whether varenicline improves the inability to feel pleasure (i.e. anhedonia), and if it is well-tolerated when used with psychiatric medications. enrolled patients will be assessed for improved mood, improved anhedonia, overall sense of health, side effects as well as tobacco use for 6-8 weeks. medication will be provided free of charge.

outpatient smokers who are depressed despite current stable psychiatric medication regimens will be invited to participate. they will receive varenicline dosed according to fda-approved smoking cessation regime; patients will be assessed using qids-sr16, snaith-hamilton anhedonia rating scale, saftee and clinical global improvement self-report scales and clinician global improvement scales at the above time intervals. concurrent medication, psychiatric and non-psychiatric, will be recorded, as will vital signs (bp, hr, weight) and tobacco use.

Eligibility criteria:
inclusion criteria: 1. meets dsm-iv symptoms criteria for a mood disorder including major depression \[unipolar or bipolar\], depressive disorder nos, dysthymia, adjustment disorder with depressed mood, or substance-induced mood disorder. 2. failed to achieve full symptom remission with previous pharmacotherapy. 3. current tobacco users. 4. able to give written, informed consent. exclusion criteria: 1. past adverse reaction to varenicline. 2. renal failure or dialysis. 3. current pregnancy or breastfeeding.

Keywords: varenicline depression anhedonia smoking
a survey of brentuximab vedotin in pediatric participants with hodgkin lymphoma

Conditions: Hodgkin Lymphoma

Summary: this study is a survey in japan of brentuximab vedotin used to treat children or teenagers with hodgkin lymphoma (hl). the study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study. the main aim of the study is to check for side effects related from brentuximab vedotin especially myelosupression, peripheral neuropathy, and lung disorder. during the study, pediatric participants with hl will take brentuximab vedotin injection and avd treatment (doxorubicin hydrochloride, vinblastine sulfate, and dacarbazine) according to their clinic's standard practice. the study doctors will check for side effects from brentuximab vedotin for 26 weeks.


Eligibility criteria:
inclusion criteria: 1. treatment-naive participants 2. cd30 positive participants 3. participants treated with the study drug in combination with doxorubicin hydrochloride, vinblastine sulfate, and dacarbazine (avd). 4. participants aged \< 18 years at the start of this drug. exclusion criteria: participants with contraindications to the study drug.
131i-mibg alone vs. 131i-mibg with vincristine and irinotecan vs131i-mibg with vorinostat

Conditions: Neuroblastoma

Summary: this study will compare three treatment regimens containing metaiodobenzylguanidine (mibg) and compare their effects on tumor response and associated side effects, to determine if one therapy is better than the other for people diagnosed with relapsed or persistent neuroblastoma.


Eligibility criteria:
inclusion criteria: * patients must be \> 24 months and \< 30 years of age when registered on study. * patients must have relapsed neuroblastoma, refractory neuroblastoma that had less than a partial response to standard treatment or persistent neuroblastoma that had at least a partial response to frontline therapy frontline therapy with \> 3 residual lesions on end-induction mibg scan. * patients must have evidence of mibg uptake into tumor at ≥ one site within 4 weeks prior to entry on study and subsequent to any intervening therapy. * patients must have adequate heart, kidney, liver and bone marrow function. patients who have bone marrow disease must still have adequate bone marrow function to enter the study. * patients must have a dose of unpurged peripheral blood stem cells is 2.0 x 106 viable cd34+ cells/kg available. exclusion criteria: * they have had previous i-131 mibg therapy * they have other medical problems that could get much worse with this treatment. * they are pregnant or breast feeding. * they have a history of a venous or arterial thrombosis that was not associated to a central line. * they have active infections such as hepatitis or fungal infections. * they have active diarrhea. * they have had an allogeneic stem cell transplant (received stem cell from someone else) * they can't cooperate with the special precautions that are needed for this trial.
self-management of anticoagulation treatment

Conditions: Atrial Fibrillation; Venous Thromboembolism; Artificial Heart Valve

Summary: the aim of the study was to compare self-management of anticoagulant treatment with conventional anticoagulant treatment in norway.

patients (n=132) on anticoagulant treatment with warfarin participated in a 21 weeks training program where they learned how to analyse international normalised ratio (inr) using the point-of-care instrument coaguchek®xs and dose warfarin. the patients had to display their skills through a test before considered self-managing. they continued to measure inr weekly for two years. all inr values during the training program and self-control period were collected. in addition, the patients were told to notify if they had any complications during this period. inr values and complications two years before enrolment was collected from inr cards and/or their general practioner. the participant filled in a quality of life-questioner at enrolment and after two years of self-management.

Eligibility criteria:
inclusion criteria: * on life-long oral anticoagulation therapy * judged to be qualified for patient self-management anticoagulation treatment by their gp * motivated to follow the training program exclusion criteria: * drug abuse * liver disease

Keywords: warfarin self-management conventional management training ttr complications quality of life
prevention program for problem behaviors in girls in foster care

Conditions: Juvenile Justice Involvement; Drug Abuse

Summary: this study will determine the efficacy of a parent-involved intervention in preventing problem behavior in middle school girls who are currently in foster care.

the transition from elementary school to middle school presents a complex set of challenges for adolescents. these include increased expectations for time management and self-monitoring, renegotiation of rules and boundaries with parents, increased peer influence, and pubertal changes. for children in foster care, this transition is further complicated by issues such as a possible history of maltreatment, unpredictable changes in their living situations, and difficulty explaining their foster care background to peers and teachers. such issues may be more serious for girls in foster care. social problems for these girls in middle school can lead to a number of negative effects, including delinquency, substance abuse, poor school performance, mental health problems, and participation in risky sexual behavior. despite such risks, adolescent girls are less likely to receive specialty mental health or school-based services than their male counterparts. this study is aimed at determining the effectiveness of a preventive intervention for preadolescent girls living in foster/kinship care. the intervention targets include preventing delinquency, initiation of substance use, participation in risky sexual behavior, school truancy and failure, and mental health problems. participants were randomly assigned to receive either the preventive intervention or usual foster care services in the summer before entering middle school (typically sixth grade). the preventive intervention consisted of weekly training and support sessions for both participants and their foster or kin parents. the sessions began at study start and continued throughout participants' first year in middle school. participants' relationship development, delinquency, school behavior and performance, sexual behavior, and substance use were assessed through questionnaires. parenting practices were assessed through interviews. assessments were conducted at study entry and at months 6, 12, and 24, and 36. a new, follow-up assessment on the girls' decision making was conducted at age 14-16.

Eligibility criteria:
inclusion criteria: * living in a foster home or receiving kinship care * are about to enter middle school * oregon resident * guardian willing to provide informed consent * female exclusion criteria: * male * not in foster care * not living in oregon

Keywords: adolescent foster care female
a study to assess the immunogenicity and safety of csl's 2012/2013 formulation of enzira® vaccine in healthy volunteers

Conditions: Influenza, Human

Summary: this is a study to assess the immune (antibody) response and safety of the 2012/2013 formulation of enzira® (csl influenza vaccine) in healthy adult volunteers aged 18 years or older.


Eligibility criteria:
inclusion criteria: * males or females aged 18 years or older at the time of vaccination. * females of child-bearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for the duration of the study. females of child-bearing potential must return a negative urine pregnancy test result prior to vaccination with the vaccine. exclusion criteria: * known hypersensitivity to a previous vaccination with influenza vaccine or allergy to eggs, ovalbumin, chicken protein, neomycin, polymyxin, or any components of the vaccine. * clinical signs of an active infection. * a clinically significant medical condition. * vaccination with a seasonal or experimental influenza virus vaccine in the 6 months preceding study entry. * females who are pregnant or lactating.
ilioinguinal/iliohypogastric block for inguinal hernia repair

Conditions: Anesthesia

Summary: inguinal hernia have traditionally been done under general anesthesia. while safe, general anesthesia is associated with potential postoperative nausea/vomiting and drowsiness. additionally, the recent covid19 pandemic has heightened the precaution to avoid aerosol generating procedures (agp) if possible. general anesthesia requires airway manipulation, thus necessitate performing an agp. recently, we began using peripheral nerve block and sedation as primary anesthetic technique for inguinal hernia repairs. while surgeon administered local anesthetic, also known as local infiltration, has been done for inguinal hernia repair, using specific nerve blocks and sedation has not been compared with general anesthesia. we believe the advantage of this novel technique can improve postoperative recovery. this retrospective study will compare the total hospital length of stay of those receiving nerve blocks and sedation as primary anesthetic techniques versus those with general anesthesia.


Eligibility criteria:
inclusion criteria: * 18 years or older * american society of anesthesiologists (asa) physical status i to iii * body mass index (bmi) less than 45 * single hernia repair, elective, ambulatory surgery exclusion criteria: * opioid dependence (30 mg oral morphine equivalents daily or more) * history of malignant hyperthermia * pregnancy
pilot study of pregnenolone augmentation targeting cognitive symptoms in persistently symptomatic patients with schizophrenia

Conditions: Schizophrenia

Summary: this is a pilot study of pregnenolone as an augmentation treatment for schizophrenia. the goal of this placebo-controlled study is to provide preliminary efficacy data for potential pregnenolone effects on cognitive symptoms and negative symptoms in patients with schizophrenia. depressive symptoms and positive symptoms will also be assessed.

see brief summary

Eligibility criteria:
inclusion criteria: 1. 18-65 years of age, any ethnic group, either sex 2. diagnostic and statistical manual, 4th edition (dsm iv) diagnosis of schizophrenia or schizoaffective disorder 3. ability to participate fully in the informed consent process, or have a legal guardian able to participate in the informed consent process. 4. patient cohort enriched for moderate to severe cognitive symptoms (composite brief assessment of cognition in schizophrenia (bacs) score 0-3 sd below the mean). 5. no change in antipsychotic for 8 weeks or longer. no change in antipsychotic dose for 4 weeks or longer. 6. no change in anticholinergic, benzodiazepine, or mood stabilizer medications for 4 weeks or longer. 7. no anticipated need to alter any of the above medications (antipsychotics, anticholinergics, benzodiazepines, or mood stabilizers) for the 10-week duration of the study. exclusion criteria: 1. unstable medical illness or neurologic illness (seizures, cerebrovascular accident); history of prostate, breast, uterine, or ovarian cancer. 2. use of oral contraceptives or other hormonal supplementation such as estrogen. 3. other concomitant medications for medical conditions will be addressed on a case-by-case base to determine if exclusionary. 4. active expression of suicidal or homicidal ideation. 5. comorbid substance dependence (other than nicotine dependence), or presenting symptoms likely substance-induced, as judged by a study physician. 6. female patients who are pregnant or breast-feeding. 7. known allergy to study medication. 8. drugs with a narrow therapeutic index (e.g. thioridazine, mesoridazine, ziprasidone, clozapine, etc) will be excluded as suggested by the federal drug administration (fda); patients taking these agents will not be eligible for this study.

Keywords: schizophrenia pregnenolone cognition negative symptoms
efficacy and safety study of mp-435 in combination with methotrexate (mtx) in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to determine the efficacy, safety, and pharmacokinetics of mp-435 administered for 12 weeks in subjects with rheumatoid arthritis (ra) on stable doses of methotrexate.


Eligibility criteria:
inclusion criteria: * subjects with a diagnosis of ra according to the diagnostic criteria of the american college of rheumatology (acr) (revised in 1987) for at least 6 months. * subjects who inadequately response for stable dose of mtx. exclusion criteria: * patients with class iv functional activity by the steinbrocker's scale. * patients who have received a biological agent in the past. * patients who have other rheumatic diseases, or who have other diseases with joint symptoms. * patients with severe or uncontrolled endocrine, psychiatric, cardiac, hematological, pulmonary, hepatic, kidney, gastrointestinal, or thyroid disease.

Keywords: rheumatoid arthritis
type 2 diabetes intervention by gut microbiota-directed diet -a open labelled rct

Conditions: Type 2 Diabetes

Summary: this study is a randomized, open labelled, placebo-controlled clinical trial. the main purpose is to verify the superior effect of gut microbiota directed diet intervention over standard diet intervention by evaluating the changes of hba1c relative to baseline at 16 weeks and 28 weeks of follow-up.


Eligibility criteria:
inclusion criteria: * newly diagnosed type 2 diabetes mellitus patients who have been diagnosed or screened for treatment without any hypoglycemic drugs; * 6.5%≤hba1c≤8.5%； * fpg\<10.0mmol/l; * bmi≥24； exclusion criteria: * suspected other types of diabetes * moderate stroke occurred within one year; * frequent diarrhea or constipation in the past 3 months (more than 4 times / week); * acute complications occurred in the past 3 months, such as infection, ketosis and acidosis; * pregnant and lactating women (or women who are currently trying to conceive, or who are likely to have children and do not use contraceptives); * drinking (1 weeks of drinking more than 5 times, on average 2 two baijiu or half jin of yellow wine or 5 bottles of beer above); * those who have received drug treatment for the following diseases in the past three months: cholecystitis, peptic ulcer, urinary tract infection, acute pyelonephritis, cystitis, hyperthyroidism and other thyroid dysfunction; * gastrointestinal surgery (except appendicitis and hernia surgery); * antibiotics have been used in the past 3 months for 3 days or more; * physical methods, such as liposuction or gastrointestinal reconstruction, have been used to lose weight in the past 3 months; * physical disability, or inability to take care of themselves, recall and answer questions clearly due to other reasons; * anemia: hemoglobin \< 10g / dl; * patients with severe liver diseases such as chronic hepatitis, persistent hepatitis and cirrhosis, and hepatitis b virus surface antigen (hbsag) positive and abnormal liver function (serum alanine aminotransferase and aspartate aminotransferase are 2.5 times the normal value). * other serious diseases, such as malignant tumors, serious mental diseases, serious infectious diseases, etc; * patients who are participating in other intervention studies; * in the judgment of the study physician, there are any conditions that affect the study compliance, such as:alcohol or drug abuse in the past 12 months; serious adverse drug treatment compliance in the past 12 months; the residence is far away from the research center, or it is planned to move far away or travel frequently in the next year; the clinical diagnosis of dementia or the judgment of cognitive function by the research physician will affect the research compliance; other medical, psychological or behavioral factors that affect the study compliance are judged by the study physician.
is gait speed and sarcopenia prognostic in chronic respiratory disease?

Conditions: Chronic Obstructive Pulmonary Disease and Allied Conditions

Summary: this study aims to assess usual walking speed (4-metre gait speed) and markers of sarcopenia predict mortality in patients with chronic respiratory disease.


Eligibility criteria:
inclusion criteria: * all patients with chronic respiratory disease who are able to complete the assessments. exclusion criteria: * significant co-morbidities that would limit walking ability, exercise capacity or make exercise unsafe (e.g. unstable ischaemic heart disease, neuromuscular disease, severe hip/lower limb joint pain, peripheral vascular disease, lower limb amputation). * any patient whom the chief investigator feels it is unsafe to exercise (e.g. unstable cardiovascular disease).

Keywords: sarcopenia
study of intratumoral hypoxia using pre-operative administration of pimonidazole

Conditions: Pancreatic Cancer

Summary: this study involves the administration of a hypoxia marker, pimonidazole hydrochloride, taken orally approximately 24 hours before surgical resection of a pancreatic tumor in order to identify areas of lower oxygen content on tumor samples.

intratumoral hypoxia (low oxygen concentration or po2) occurs when oxygen consumption exceeds its delivery by the vascular system. hypoxia is associated with adverse patient outcome in many human cancers and this association is hypothesized to be due to a combination of treatment resistance and aggressive tumor biology. the study of hypoxia is also important as new cancer drugs are being developed that are specifically active on cancer cells in area of tumors with lower oxygen levels. his study involves administering the hypoxia probe pimonidazole hydrochloride to patients prior to resection of pancreatic adenocarcinoma to evaluate the extent, molecular context and clinical relevance of hypoxia in clinical pancreatic cancer samples and the subsequently derived primary xenograft tumors. we propose accrual of patients over a 5-year period to evaluate hypoxia within 100 clinical tumor specimens and corresponding primary xenograft tumours where available. the complementary techniques of wide-field multicolor fluorescence image analysis microscopy and high level flow cytometry will be used to identify potential relationships between intratumoral hypoxia and cell proliferation, differentiation, and the expression of putative cancer stem cell markers.

Eligibility criteria:
inclusion criteria: * age \> 18 * provisional diagnosis of pancreatic cancer * scheduled resection at uhn * consented to icgc pancreatic cancer genome project * surgery planned for \>2 days away (drug administration has to be 16-20hrs before surgery) exclusion criteria: * not participating in icgc * contraindications to pimonidazole (allergy) * surgery scheduled for same or next day (not enough time to arrange for drug administration)

Keywords: pancreas pancreatic cancer pancreatic tumor pimonidazole hypoxia whipple's resection
ultrasound simulation case-based workshop implementation and impact assessment

Conditions: Point-of-care Ultrasound; Simulation Training; Medical Education in Emergency Ultrasound

Summary: this study is a prospective cohort study implementing a point-of-care ultrasound (pocus) simulation case-based workshop in emergency (em) physicians at different training levels as an educational and competency-based assessment tool. the investigators incorporate elements of miller's pyramid (second and third levels of "knows how" and "shows how") and the latter part of kern's six step model framework for curriculum development (intervention implementation and student assessment, program evaluation, and feedback). the investigators will compare pre-/post-workshop knowledge and post-osce (objective structured clinical exam) technical skills scores. the investigators will also collect demographic data on baseline pocus scans completed, training level, interest in ultrasound fellowship, monthly performed clinical pocus scans, etc. the standardized simulation cases for em pocus training can then be generalized for use at any program globally to improve clinical training and patient care.


Eligibility criteria:
inclusion criteria: * emergency medicine physicians exclusion criteria: * emergency medicine nurses * emergency medicine technicians * advanced practice providers (apps)

Keywords: point-of-care ultrasound simulation training medical education
a therapeutic equivalence study of two metronidazole gel 1% topical treatments of rosacea

Conditions: Papulopustular Rosacea; Erythematotelangiectatic Rosacea

Summary: the purpose of this study is to compare the efficacy of two metronidazole gels 1%, in the treatment of rosacea.


Eligibility criteria:
inclusion criteria: * male or female subjects with at least 18 years of age; * read and signed icf; * clinical diagnosis of rosacea; exclusion criteria: * females who are pregnant, lactating or of childbearing potential who are not using or do not agree to use an acceptable form of contraception; * any skin condition that would interfere with treatment of rosacea * use of prohibited medications